Data / Medical devices / United States / Aspira Women's Health, Inc.
Aspira Women's Health, Inc.: FDA-registered device maker in Austin, TX, United States, 2 510(k) clearances
Aspira Women's Health, Inc. is registered with the FDA (registration 3004869564) in Austin, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 18, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004869564
- Address
- 12117 FM2244 #3 suite 100, Austin, TX, United States, 78738
- Owner or operator
- Aspira Women's Health (9077721)
- Roles
- Manufacturer
- First device listed
- December 29, 2009
- Registered through
- 2026
- Brand names listed
- OVA 1 Test, Overa
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ovarian Adnexal Mass Assessment Score Test System | ONX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 18, 2016 | K150588 | OVA1 Next Generation | ONX | Substantially Equivalent | Vermillion, Inc. | accessdata.fda.gov |
| September 11, 2009 | DEN090004 | OVA1 TEST | ONX | Unknown | Vermillion | accessdata.fda.gov |
Compare with other makers
Updated March 18, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.